Вакансия: Quality Assurance Specialist
от компании (организации): Kelly Services в городе (населенном пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Сертификация"
с оплатой труда: по договоренности
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Вакансия № 14653434 добавлена в базу данных сайта Электронный Центр Занятости Населения: Суббота, 17 мая 2025 года.
Дата обновления вакансии № 14653434 на сайте Электронного Центра Занятости Населения: Воскресенье, 29 июня 2025 года.
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Требования к опыту работы: 1–3 года
Тип занятости: полная занятость
График работы: полный день
Дополнительные сведения о вакансии: Quality Assurance Specialist
The international pharmaceutical company is looking for a Quality Assurance Specialist.
Main responsibilities:
- Collaboration with Commercial and State laboratories in terms of execution of necessary tests and management of standards and reagents.
- Translation of CoAs for imported batches of medicinal products. Communication with translation agencies, ensure timely translation of documents needed for Local Batch Release process.
- Ensure the accuracy and quality of the records related to Local Batch Release process.
- Organize and maintains system of storage, archiving and (where necessary) retrieval of necessary records relating to Local Batch Release process and other duties entrusted.
- Work with commercial standards and reagents necessary for testing handling, namely:
- Order management;
- Importation process;
- Customs clearance;
- Warehousing;
- Delivery management (including hand-over process);
- Stock control and reconciliation
- Assists or leads the development, and ongoing execution of the Quality Agreement with Broker, State and Commercial laboratories, other service providers.
- Collaboration with Broker and Commercial Standards Provider on standards and reagents management.
- Coordinates all financial documentation and reporting on duties entrusted.
- Collaboration with Commercial/State laboratories, Broker and Commercial Standards Provider in terms of contracting (prolongations).
- Track and monitor operational and quality performance of the Commercial/State laboratories and Broker.
- Assures compliance with established policies/procedures and complies with all applicable governmental regulations (GMP, GDP, local legislation, etc.).
- Supporting (assisting) Senior Specialist Quality Assurance in all actions related to problems, non-conformities, deviations revealed during local batch release process connected with any assigned actions.
- Assures all actions on duties entrusted to him to prevent stock out situation in the market are timely executed
- Participates in EHS, Business Compliance, cGMP/GDP and all other compliance-related matters, where applicable.
- Ensures both operational knowledge and technical skills are maintained and compliant against individual training requirements.
Qualifications:
- Degree in a relevant science, preferably BS Pharmacy, Chemistry, Chemical Engineering, Biology, Biotechnology (or equivalent) education
- Basic knowledge of local pharmacopeia articles, normative documentation, medicines state registration process.
- Basic knowledge of quality confirmation/local certification
- Experience and knowledge in the field of logistics (importation, customs clearance, warehousing, transportation including cold chain)
- Experience in the field of GMP/GDP and other applicable local legislation is preferable
Skills Required:
- At least 2 years’ experience in the pharmaceutical industry preferably with knowledge of Quality Systems, Quality Assurance and Quality Control including basic knowledge of global GMP/GDP and regulatory requirements as a must.
- Competent in scientific problem solving and risk analysis capabilities.
- Strong compliance mind-set and demonstrated interpersonal skills including coaching, ability to motivate others, communicate effectively and negotiate as needed.
- Demonstrates a way of working which is proactive and self-motivated, with an ability to multi-task.
- Organizational skills and some level of contractual and financial awareness is preferred.
- Proficiency in Russian and English.
Откликнуться на эту вакансию № 14653434: Quality Assurance Specialist
Предыдущая вакансия:
Вакансия № 14653436 на должность Аудитор от компании Crowe CRS в городе (населенном пункте) Москва